(1) Field of the Invention
The present invention relates generally to soft gelatin capsules and to a process for their preparation, and in particular to soft gelatin capsules having a chewable consistency.
(2) Description of the Prior Art
Soft gelatin capsules are comprised of a gelatin sheath encapsulating a fill of a medicament, vitamin, or other material to be consumed by the user. The one-piece gelatin sheath or shell includes a plasticizer, normally glycerin or sorbitol, to control the softness and flexibility of the sheath. The sheath also includes water, and optionally, other additives, such as flavorants. The fill is normally comprised of a carrier in which the active material is dissolved or suspended.
Chewable soft gelatin capsules, or chewable softgels, are designed so that the user chews upon the capsule to release the fill into the mouth instead of swallowing the capsule with the fill still encapsulated within the sheath. Chewable capsules are particularly suitable for administering analgesics, vitamins, minerals and cold remedies. After the fill has been released, the user chews the fractured sheath until it is partially or completely dispersed. In an alternative embodiment described in U.S. Pat. No. 4,428,927, a chewing gum base material is incorporated into the sheath and the sheath is not made for swallowing.
Therefore, acceptable sheath formulations must not only have sufficient integrity to encapsulate the fill without leakage prior to consumption, they must also be readily soluble or dispersible when chewed. In addition, the formulations must not be of a sticky or tacky nature during processing, interfering with the conversion of the gelatin mass into sheaths in conventional encapsulation equipment.
While an effective delivery system, the acceptance of chewable softgels has been limited by the mouth-feel or texture of the sheath, which is commonly perceived to be leathery or rubbery, and the difficulty in consuming the fractured sheaths after the fill has been released. The use of chewable softgels could be significantly expanded if this problem could be overcome.